REBEL™ H7493927420400Recalls & reported problems
Boston Scientific Corporation · Platinum Chromium Coronary Stent System · Class 3
All models of REBEL (24)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729843870), received between Jul 15, 2019 and Oct 7, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
1 other recall cover devices cleared under the same FDA submission (P130030); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Difficult to Advance1
- Material Deformation1
Patient problems
- No Code Available1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 7, 2020Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL ARTERY. A 20 X 4.00MM REBEL BMS STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THERE WAS DIFFICULTY ADVANCING THE GUIDE AND THE STENT STRUTS WERE BENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT WITH THE SAME GUIDEZILLA. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10643220 ↗InjuryJul 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. A 20 X 4.00 REBEL DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT IT FAILED TO CROSS THE LESION. IT WAS THEN NOTED THAT THE STENT FELL OFF THE BALLOON IN THE OSTIUM OF THE RIGHT CORONARY ARTERY WHERE IT HAD TO BE SNARED. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Code Available
MAUDE report 8789502 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P130030. One submission often covers many models, so check the product and lot details in each record.
- Z-0580-2020 · Oct 24, 2019 · TerminatedRebel Monorail PtCr Coronary Stent System, REF / Catalog No. H7493927324300, Rebel MR OUS 3.0mm x 24mm. The Rebel Monorail (MR) Stent System is a balloon expandable Platinum Chro
Other STENT, CORONARY devices
- WALLSTENT® Endoprosthesis H965403130Boston Scientific Corporation · STENT, CORONARY35 reports
- WALLSTENT® Endoprosthesis H965402130Boston Scientific Corporation · STENT, CORONARY23 reports
- Tryton Side Branch Stent T5-2530-191-USTryton Medical, Inc. · Stent, Coronary1 death22 reports
- WALLSTENT® Endoprosthesis H965403330Boston Scientific Corporation · STENT, CORONARY21 reports
- WALLSTENT® Endoprosthesis H965403320Boston Scientific Corporation · STENT, CORONARY10 reports
- WALLSTENT® Endoprosthesis H965403120Boston Scientific Corporation · STENT, CORONARY9 reports
- Tryton Side Branch Stent T5-3035-151-USTryton Medical, Inc. · Stent, Coronary2 deaths7 reports
- MULTI-LINK VISION 1007850-15Abbott Vascular Inc. · STENT, CORONARY7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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